Devices and methods for manipulating circulation in the circulatory system of a patient

Abstract

A device for manipulating circulation in the circulatory system of the body of a subject is disclosed. The device includes a flexible support dimensioned for covering a section of the body of the subject, a vibration inducing element embedded in or attached to the support. The support includes a patch and an attachment layer on the patch. The attachment layer includes a biocompatible adhesive suitable for attaching the patch to skin on the section of the body of the subject. The vibration inducing element is positioned in or on the support such that the vibration inducing element can transmit vibrations to the skin when the patch is adhered to the skin on the section of the body of the subject.

1 - 98 . (canceled) 
     
     
         99 . A device for manipulating circulation in the circulatory system of the body of a subject, the device comprising:
 a flexible support dimensioned for covering a section of the body of the subject; and   a vibration inducing element embedded in or attached to the support,   wherein the support includes a patch and an attachment layer on the patch, the attachment layer including a biocompatible adhesive suitable for attaching the patch to skin on the section of the body of the subject, and   wherein the vibration inducing element is positioned in or on the support such that the vibration inducing element can transmit vibrations to the skin when the patch is adhered to the skin on the section of the body of the subject.   
     
     
         100 . The device of  claim 99  wherein:
 the support includes an opening dimensioned to fully or partially surround a wound on the section of the body of the subject when the patch is placed over skin on the section of the body of the subject. 
 
     
     
         101 . The device of  claim 99  further comprising:
 a power source; and 
 a controller in electrical communication with the vibration inducing element and the power source, the controller being configured to execute a program stored in the controller to provide an electrical signal to the vibration inducing element, the electrical signal controlling timing, frequency, amplitude, waveform, force and/or other parameters of operation of the vibration inducing element, the electrical signal being (i) a single or multiple waveform, (ii) unidirectional or multidirectional, and (iii) sinusoidal, square, pulse, triangle or a combination thereof. 
 
     
     
         102 . The device of  claim 101  wherein:
 the controller is further configured to execute the program to:
 (v) cease providing the electrical signal to the vibration inducing element or decrease intensity of the electrical signal provided to the vibration inducing element or increase intensity of the electrical signal provided to the vibration inducing element for a first time duration, and 
 (vi) resume providing the electrical signal to the vibration inducing element or increase intensity of the electrical signal provided to the vibration inducing element or decrease intensity of the electrical signal provided to the vibration inducing element for a second time duration. 
 
 
     
     
         103 . The device of  claim 101  wherein:
 at least one of the frequency and the amplitude and the force of vibrations of the vibration inducing element during the third time duration is different than the frequency and the amplitude and the force of vibrations of the vibration inducing element during the first time duration. 
 
     
     
         104 . The device of  claim 99  further comprising:
 a second vibration inducing element embedded in or attached to the support; 
 a power source; and 
 a controller in electrical communication with the first vibration inducing element and the second vibration inducing element and the power source, the controller being configured to execute a program to:
 (i) provide a first electrical signal for a first time duration to the vibration inducing element, the first electrical signal controlling the frequency and amplitude and force of vibrations of the vibration inducing element, 
 (ii) cease providing the first electrical signal to the vibration inducing element for a second time duration, and 
 (iii) provide a second electrical signal to the second vibration inducing element for a third time duration, the second electrical signal controlling the frequency and amplitude and force of vibrations of the second vibration inducing element. 
 
 
     
     
         105 . The device of  claim 99  further comprising:
 a power source; and 
 a controller in electrical communication with the vibration inducing element and the power source, the controller being configured to execute a program to:
 (i) provide a first electrical signal to the vibration inducing element, the first electrical signal controlling the frequency and amplitude and force of vibrations of the vibration inducing element, and 
 (iii) vary the first electrical signal to the vibration inducing element such that at least one of the frequency or amplitude or force of vibrations of the vibration inducing element is varied. 
 
 
     
     
         106 . The device of  claim 99  further comprising:
 a perfusion sensor for covering a second section of the body of the subject, the second section being adjacent to or within the first section of the body of the subject; 
 a power source; and 
 a controller in electrical communication with the vibration inducing element and the power source and the perfusion sensor, the controller being configured to execute a program stored in the controller to:
 (i) provide a first electrical signal for a first time duration to the vibration inducing element, the first electrical signal controlling the frequency and amplitude and force of vibrations of the vibration inducing element, and 
 (ii) vary the first electrical signal provided to the vibration inducing element based on a second electrical signal received from the perfusion sensor. 
 
 
     
     
         107 . The device of  claim 106  wherein:
 the perfusion sensor is selected from piezo-film sensors, temperature sensors, photoplethysmographic sensors, strain-gauge plethysmography sensors, laser Doppler sensors, laser speckle sensors, infra-red imaging, infra-red spectroscopy, and ultrasound sensors. 
 
     
     
         108 . The device of  claim 99  further comprising:
 a vibration sensor for covering a second section of the body of the subject, the second section being adjacent to or within the first section of the body of the subject; 
 a power source; and 
 a controller in electrical communication with the vibration inducing element and the power source and the vibration sensor, the controller being configured to execute a program stored in the controller to:
 (i) provide a first electrical signal for a first time duration to the vibration inducing element, the first electrical signal controlling the frequency and amplitude and force of vibrations of the vibration inducing element, and 
 (ii) vary the first electrical signal provided to the vibration inducing element based on a second electrical signal received from the vibration sensor. 
 
 
     
     
         109 . The device of  claim 99  wherein:
 the support comprises a patch formed from a material selected from silicone, synthetic foam, polyethylene, polyurethane, polyvinyl chloride, plastic, thermoplastic polyurethane, polypropylene, fabric, hydrogel, collagen, alginate, gelatin, or combinations thereof. 
 
     
     
         110 . The device of  claim 99  wherein:
 the vibration inducing element is selected from linear electromagnetic actuators, asymmetric mass motors, voice coils, electro-active polymers, piezoelectric actuators, fluid-containing resonating elements, gas-containing resonating elements, and combinations thereof. 
 
     
     
         111 . The device of  claim 99  wherein:
 the vibrations of each vibration inducing element range from 1 Hz to 15,000 Hz. 
 
     
     
         112 . The device of  claim 99  wherein:
 the vibrations of each vibration inducing element have an amplitude ranging from 0.001 to 2.5 millimeters 
 
     
     
         113 . The device of  claim 99  wherein:
 the vibrations of each vibration inducing element have a force ranging from 0.001 Newtons to 100 Newtons. 
 
     
     
         114 . The device of  claim 99  wherein:
 the section of the body of the subject includes a wound and the wound is selected from the group consisting of diabetic ulcers, ischemic ulcers, venous ulcers, arterial ulcers, ischemic wounds, pressure wounds, injuries, surgeries, surgical incisions, surgical wounds, burns, inflammation, muscle injuries, muscle inflammation, musculo-skeletal injuries, and internal injuries, and the device further includes a hydrogel matrix selected from polylactic acid, polyglycolic acid, other polyhydroxy acids, copolymers of two or more polyhydroxy acids, polyorthoesters, polyanhydrides, gelatin, collagen, cellulose, derivatized cellulose, chitosan, alginate, thiol-modified hyaluronan, emulsion, and combinations or copolymers thereof for covering the wound. 
 
     
     
         115 . The device of  claim 99  further comprising:
 at least one of: devices for applying negative pressure below or adjacent to the support, hyperbaric oxygen devices, compression devices, shock wave devices, heating devices, cooling devices, light emitting devices, ultrasound devices, electro-magnetic stimulation devices, magnetic stimulation devices and electric current stimulation devices. 
 
     
     
         116 . A treatment method comprising:
 positioning the support of the device of  claim 99  adjacent to or on the skin on the section of the body of the subject; and   activating the device to transmit vibrations to the skin,   wherein the method is a method selected from the group consisting of a method for enhancing skin appearance, a method for the treatment of sport injury by enhancing healing, a method for enhancing healing after surgery, a method for treating peripheral artery disease or peripheral vascular disease in a subject, a method for improving wound healing in a subject, a method for increasing tissue oxygenation in a subject, a method for improving healing of a skin ulcer in a subject, a method for improving blood flow to ischemic tissue in a subject, a method for treating erectile dysfunction, a method for treating a migraine, a method for treating hair loss, and a method for treating neuropathy.   
     
     
         117 . A device for manipulating circulation in the circulatory system of the body of a subject, the device comprising:
 a flexible dermal patch dimensioned for covering a section of the body of the subject, the patch including a porous layer structured such that fluid can pass from a first side of the porous layer to an opposite second side of the porous layer, the patch further including an impermeable outer layer covering the second side of the porous layer, and the patch further including a fluid passageway extending from the second side of the porous layer to an outer surface of the outer layer, the fluid passageway terminating at a hollow connector at the outer surface of the outer layer,   wherein the connector, the fluid passageway and the porous layer are structured such that when the first side of the porous layer of the patch is positioned on the section of the body of the subject and the connector is connected to a source of negative pressure, negative pressure is inflicted on the section of the body of the subject under the patch whereby blood flow is increased.   
     
     
         118 . A treatment method comprising:
 applying the patch of the device of  claim 117  to skin; and   applying negative pressure on the skin of the section of the body of the subject under the patch,   wherein the method is a method selected from the group consisting of a method for enhancing skin appearance, a method for the treatment of sport injury by enhancing healing, a method for enhancing healing after surgery, a method for treating peripheral artery disease or peripheral vascular disease in a subject, a method for improving wound healing in a subject, a method for increasing tissue oxygenation in a subject, a method for improving healing of a skin ulcer in a subject, a method for improving blood flow to ischemic tissue in a subject, a method for treating erectile dysfunction, a method for treating a migraine, a method for treating hair loss, and a method for treating neuropathy.